A Study of 2-dose Vaccine Regimen Using 3 Consecutive Lots of Ad26.ZEBOV and MVA-BN-Filo in Adult Participants

Antibody GMCs against the EBOV GP as measured by ELISA at 21 days post Vaccination 2 were reported. GMCs of antibodies binding to EBOV GP using ELISA were reported and were measured in ELISA units per milliliter (EU/mL). Serum samples were collected for analysis of binding antibodies against EBOV GP using ELISA to determine humoral responses following vaccination. For ELISA binding antibody responses, values below the lower limit of quantification (LLOQ) of 36.11 EU/mL were imputed with half of the LLOQ prior to the computation of the GMCs.

Time frame: 21 Days Post Vaccination 2 (Day 78)

Population: Per protocol (PP) analysis set included all randomized (Group 1-4 only) and vaccinated participants, who received Dose 1 and Dose 2 vaccinations, and booster vaccination (Groups 5 and 6 only) (administered within protocol-defined window), had at least 1 post vaccination (after date of vaccination) evaluable immunogenicity sample, had no major protocol deviations influencing the immune response. N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure.

Antibody GMCs against the EBOV GP as measured by ELISA at 56 days post Vaccination 1 were reported. GMCs of antibodies binding to EBOV GP using ELISA were reported and were measured in ELISA units per milliliter (EU/mL). Serum samples were collected for analysis of binding antibodies against EBOV GP using ELISA to determine humoral responses following vaccination. For ELISA binding antibody responses, values below the LLOQ of 36.11 EU/mL were imputed with half of the LLOQ prior to the computation of the GMCs.

Time frame: 56 Days Post Vaccination 1 (Day 57)

Population: PP analysis set included all randomized (Groups 1-4 only) and vaccinated participants, who received Dose 1 and Dose 2 vaccinations, and booster vaccination (Groups 5 and 6 only) (administered within protocol-defined window), had at least 1 post vaccination (after date of vaccination) evaluable immunogenicity sample, had no major protocol deviations influence the immune response. Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure.

SAE was any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.

Time frame: Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6

Population: FAS included all participants with at least one study vaccine administration documented.

An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for 7 days post vaccination. Solicited local AEs were injection site pain/tenderness, erythema, induration/swelling, itching, pruritis at the vaccination site.

Time frame: Until 7 Days after Vaccination 1 on Day 1 (Up to Day 8); Until 7 Days after Vaccination 2 on Day 57 (Up to Day 64)

Population: Full analysis set (FAS) included all participants with at least one study vaccine administration documented. Here, n (number analyzed) signifies number of participants who were analyzed at the specified timepoints.

An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Participants recorded the temperature in the e-Diary in the evening of the day of vaccination, and then daily for the next 7 days approximately at the same time each day. If more than 1 measurement was made on any given day, the highest temperature of that day was recorded in the e-Diary. Fever was defined as endogenous elevation of body temperature greater than or equal to (\>=) 38.0 degree Celsius or \>=100.4-degree Fahrenheit, as recorded in at least 1 measurement. Participants also noted the signs and symptoms in the e-Diary on a daily basis for 7 days post vaccination 1 and 2 (day of vaccination and the subsequent 7 days), if feasible, for the following events: fatigue, headache, nausea, myalgia, arthralgia, chills, and fever.

Time frame: Until 7 Days after Vaccination 1 on Day 1 (Up to Day 8); Until 7 Days after Vaccination 2 on Day 57 (Up to Day 64)

Population: FAS included all participants with at least one study vaccine administration documented. Here, n (number analyzed) signifies number of participants who were analyzed at the specified timepoints.

An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Unsolicited AEs were all AEs for which the participant was not specifically questioned in the participant diary.

Time frame: Until 28 Days After Vaccination 1 on Day 1 (Up to Day 29); until 28 days after Vaccination 2 on Day 57 (Up to Day 85)

Population: FAS included all participants with at least one study vaccine administration documented. Here, n (number analyzed) signifies number of participants who were analyzed at the specified timepoints.